Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

Diabetes Mellitus Clinical Trial

Official title:

Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01016457
• Other study ID #: SHEBA-07-4980-KMA-CTIL
• Status: Recruiting
• Phase: Phase 4
• First received: November 18, 2009
• Last updated: November 18, 2009
• Start date: December 2008
• Est. completion date: December 2009

Study information

• Verified date: November 2009
• Source: Sheba Medical Center
• Contact: Kineret Mazor-Aronovitch, MD
• Phone: 972-3-5305022
• Email: kineret[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare glucose control, quality of life and number of hypoglycemias in preschool children before and after using a real-time glucosensor. Nocturnal hypoglycemia can be missed even when the parents check their children's blood glucose several times at night. The investigators hypothesise that nocturnal hypoglycemia can be prevented by using the sensor in this age group. As a consequence, quality of life of the families will improve. The investigators also hypothesise that diabetes control will improve at 3-6 months from the beginning of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

Inclusion Criteria:

• Duration of diabetes for more than 6 months

• Use of insulin pump for more than 3 months

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Device:
• Guardian RT
The sensor is inserted similarly to the insulin pump. It measures sub cutaneous glucose every 5 minutes. It alerts of high and low glucose levels, according to set limits.

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1C		Start of study, after 3 months, after 6 months	Yes
Secondary	Quality of life		Before and after connecting to sensor	No
Secondary	Number of night hypoglycemias		During 2 weeks before connecting to sensor, during connection and 3 montjs after disconnecting	Yes
Secondary	Mean glucose level		During the first week of connecting to sensor and during the last week of connecting	Yes